A “one-shot” flu-treatment breakthrough is the hoped-for outcome of phase III trials due to begin in Japan, Taiwan, Hong Kong and Korea.
Daiichi Sankyo’s CS-8958 drug is a long-acting neuraminidase inhibitor (LANI) that has shown promise against the H5N1 avian influenza virus as well as influenza A and B.
It is expected that a single inhalation will be as effective as 75mg of oseltamivir administered orally twice daily for five days.
The double-blind non-inferiority study will use symptom resolution and fever as its endpoints after a single inhaled dose. The safety of CS-8958 will also be assessed.
The study is named MARVEL (Multinational Asian clinical Research for influenza Virus Extermination on LANI). In the phase II/III trial for paediatrics, it is hoped that symptom resolution and fever with the same dose regimens will be confirmed.
Copyright Press Association 2008